Class III · Low risk Ongoing
Tropicamide 1%
Reason Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
LET Gel
Reason Product Mix-up: Incorrect Product Formulation
Class III · Low risk Terminated
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP
Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class III · Low risk Terminated
V-FORCE Homeopathic
Reason Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Class III · Low risk Terminated
Lisinopril Tablets USP 20 mg
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class III · Low risk Terminated
Buspirone Hydrochloride Tabs USP 10 mg
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class III · Low risk Terminated
Mycophenolate Mofetil for Oral Suspension
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class III · Low risk Ongoing
Oxaydo
Reason Sub-potent Drug: Lower potency than labeled.
Class III · Low risk Terminated
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Opium Tincture
Reason Subpotent Drug
Class III · Low risk Terminated
Aminocaproic Acid Oral Solution
Reason Failed Excipient Specifications: high content of ethylene glycol (EG)
Class III · Low risk Ongoing
Synthroid
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class III · Low risk Terminated
VANCOmycin HCI PF
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
VANCOmycin HCI PF
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
Oxytocin synthetic
Reason Labeling: Not Elsewhere Classified
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets USP
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Epinephrine-Lidocaine HCl
Reason Subpotent: Failing Test Results for Epinephrine
Class III · Low risk Ongoing
Methotrexate Tablets
Reason Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class III · Low risk Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Reason Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk Terminated
Eligard
Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class III · Low risk Terminated
Cequa
Reason Subpotent: Out of Specification result observed for low assay
Class III · Low risk Terminated
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Reason Incorrect/Undeclared Excipients.
Class III · Low risk Terminated
HydrALAZINE Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class III · Low risk Terminated
Clearasil Rapid Rescue Deep Treatment Pads
Reason Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.